Institutional Review Board

Scenario 1

MU IRB is the IRB of Record – Submission Process
  1. The local investigator, presumably the PI, will complete and submit the appropriate application for MU IRB review and approval located in eCompliance for review and approval.
  2. The local investigator will work directly with the IRB offices involved to aid in executing the IRB Authorization Agreement(s).
  3. The local investigator must comply with the Multi-Site Research PI Responsibilities Guidance Document when MU is the lead site.
  4. The local researchers and other research sites must comply with MU policies and procedures.
  5. General Reporting and Other Responsibilities (unless otherwise indicated in the agreement):

    • The MU PI or designee will act as a single liaison for relying sites
    • Obtain local context information from relying sites, if necessary, to include in the IRB submission.
    • Coordinate the approval of the initial protocol as well as its subsequent amendments. The MU PI must ensure that the relying sites are using the correct and current version of the protocol and supportive documents.
    • Report local and relying site's potential unanticipated problems and non-compliance to the MU IRB, according to MU policies.
    • Communicate all MU IRB decisions and determinations to the relying site's study contact.
    • Identify an overall study contact for the IRBs relying on the MU IRB.
    • Select qualified sites for participation and oversee IRB approvals and/or reliance agreements.
    • Ensure all relying site investigators are trained on the MU policies and procedures, conduct of the protocol, study procedures, and reporting requirements.
    • Monitor progress and oversee the conduct of the study at the MU site and all relying sites.
    • Manage all regulatory documents/binders.
    • Responsible for the analysis, reporting, integrity, and accuracy of data.
    • Report MU and relying site's unanticipated problems and non-compliance to the MU IRB, according to MU policies.
    • Documentation of regular communication with relying sites.
    • Comply with all stipulations outlined in the Authorization Agreement or sponsor agreements.

Adding a Relying Site to an Existing IRB Approved Study: Some sites may be added after the initial IRB approval has already been obtained. If a site wishes to rely on an existing IRB approval, an Amendment Form must be filed to add the site(s) and investigator(s) as well as executing the authorization agreement. Within the Amendment sub-form section, the Relying on the MU IRB sub-form must be selected and completed with the necessary site information.

 

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